Clearance Summary
STARSHIELD V3 RF TRNT received FDA 510(k) clearance under submission number K050237, sponsored by Odin Medical Technologies , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-03-18.
- Submission: K050237
- Applicant / Sponsor: Odin Medical Technologies , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2005-03-18
Classification & Regulation
This clearance is catalogued under FDA product code LNH and 21 CFR 892.1000, within the Radiology review panel as a Class II device.